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Description:  The Subject Data Entry component of a StudyTRAX project is commonly referred to as the "Patient Portal".  It is an inclusive entity of the StudyTRAX database which enables the subject to actively participate in the study process remotely.  This component can be enabled on a per study basis, by selecting the "Subject Login" feature, from within the Project Overview page. 

See "Subject Data Entry SETUP" wiki page for more details. (Link which provides specific how-to instructions on feature setup)

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Overview: Subject Data Entry is utilized for various reasons.  For practical purposes, it is utilized to collect study information from the subject/patient.  However, it has also been utilized as a mechanism to collect in-house study information itself.  This can include information that staff may enter from various sites in order to keep up-to-date on study administrative details. 

  • Most common uses as a Subject Data Entry Portal...

Pre-study
1. Remotely capture demographic and/or screening information from study candidates to determine eligibility only.

2. Provide consent and documentation to remotely enroll study candidates for inclusion on one or multiple studies.

In-Study
1. Utilize email reminders to remotely provide forms and capture study information, which can be filled out per study collection schedule...Both retrospectively or longitudinally.

2. Deliver reports to subjects regarding study progress, or, educational documentation involving any aspect of the study.  These reports can information that is tied directly to the collection schedule.  Any one subject report can output text and multimedia, based on logic driven form data entry.

Post-Study
1. Utilized for feedback questionnaires, followup tracking and additional non-study related inquires.

                                                                

Things to consider:  A standard "Patient Portal" template should be designed that is best suited for the cohort that will utilize it.  While several components of the portal are set by the system by default, there are sections on the portal that can be manipulated, to further assist the visitors experience.  Keep in mind, that the customizable regions of the portal can be modified at each data collection interval.

See Examples:  (link to examples of layout)

  • Branding of portal-  Since display space is limited horizontally for institution branded images, visitor instructions and alternative Non-CRF documentation, how much information needs to be included prior to filling out study related forms?  What is the technical experience, age of the subject?  Are there visual or hearing impairments involved?  (Font size, tutorial needed to explain portal environment)
  • Form Design - How many forms need to be filled out by the visitor at each collection interval?  How much time should be spent by the subject at any one visit to the portal?  (e.g.  Will impact vertical depth of middle panel, as well as impact the patients time availablity for any one collection period).  Will the visitor be able to modify the form data at any time, or should it be limited to a collection period?  Is there a need for supportive multimedia in the forms to be completed?
  • Reports and educational materials - This section can be reserved for static documentation, or, reports specifically designed to make use of the subjects study data.  Much like a clinic note or subject level report is customized for the staff, these same reports can be customized to fit the subject as well.
  • Limitations:
  1. The portal does not include the ability to fill out subject variables that are defined in the system-setup area of a project.
  2. While entering data on forms via the subject portal, StudyTRAX is unable to hide/show entire forms based on selections from other forms. (e.g. Interval expressions using hide/show).
  3. The portals interval completion status is only reflective of the all forms selected for the entire interval, including those that cannot be filled out by the subject.
  4. The portal cannot be utilized to directly query and post the patients medical information. (e.g. pull up EMR or demographic information)
  5. The subject is unable to query identifiable information regarding other subjects.
  6. Dataset level study data cannot be delivered to the subject as a report.
  7. The subject is unable to change their username.
  8. There is not a formal mechanism for the subject to voluntarily dismiss themself from the study.  (e.g. provide an immediate way to refuse additional scheduling of study events, subject's inability to enter universal notes regarding study questions, outside of the forms.  Perhaps a built in messenger component?)
  9. While unlikely a need, a single patient portal is unable to utilize information from two separate customer installations.
  10. Subjects are unable to select which forms to complete as an optional method to reach full completion status.
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